Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone

This study is currently recruiting participants.

Verified by Novartis, April 2009

First Received: October 23, 2008 Last Updated: April 3, 2009 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00778921

Purpose

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.

Condition	Intervention	Phase
Hypertension	Drug: Amlodipine 10 mg Drug: Aliskiren/Amlodipine 150/10 mg Drug: Aliskiren/Amlodipine 300/10 mg	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	A Randomized, Eight Week Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy

Further study details as provided by Novartis:

Primary Outcome Measures:

Vital signs at every visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Vital signs at every visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Adverse event at every visit [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Biomarker assessment at visit 2 (single blind run in), visit 5 (randomization), and visit 9 (EOS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	726
Study Start Date:	October 2008
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Amlodipine 10 mg	Drug: Amlodipine 10 mg Amlodipine 10 mg
2: Experimental Aliskiren/Amlodipine 150/10 mg	Drug: Aliskiren/Amlodipine 150/10 mg Aliskiren/Amlodipine 150/10 mg
3: Experimental Aliskiren/Amlodipine 300/10 mg	Drug: Aliskiren/Amlodipine 300/10 mg Aliskiren/Amlodipine 300/10 mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and < 110 mmHg at Visits 1 and 2
Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2
All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 5 (randomization)

Exclusion Criteria:

Severe hypertension
Pregnant or nursing (lactating) women
Pre-menopausal women not taking accepted form of birth control
Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
History of cardiovascular conditions
Uncontrolled Type 1 or Type 2 diabetes mellitus
Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778921

Contacts

Contact: Novartis

862-778-8300

Locations

Argentina
Investigative Site	Recruiting
Buenos Aires, Argentina
Contact: Novartis 862-778-8300
Germany
Investigative Site	Recruiting
Berlin, Germany
Contact: Novartis 862-778-8300
Norway
Investigative Site	Recruiting
Oslo, Norway
Contact: Novartis 862-778-8300
Poland
Investigative Site	Recruiting
Warsaw, Poland
Contact: Novartis 862-778-8300
Slovakia
Investigative Site	Recruiting
Bratislava, Slovakia
Contact: Novartis 862-778-8300
Sweden
Investigative Site	Recruiting
Stockholm, Sweden
Contact: Novartis 862-778-8300
Turkey
Investigative Site	Recruiting
Ankara, Turkey
Contact: Novartis 862-778-8300

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CSPA100A2304
Study First Received:	October 23, 2008
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00778921 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Germany: Federal Institute for Drugs and Medical Devices; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Sweden: Medical Products Agency; Slovakia: State Institute for Drug Control; Turkey: Ministry of Health

Keywords provided by Novartis:

Aliskiren
Amlodipine
Non-responder to Amlodipine

Study placed in the following topic categories:

Calcium, Dietary
Vasodilator Agents
Essential Hypertension
Vascular Diseases
Calcium Channel Blockers

Cardiovascular Agents
Antihypertensive Agents
Amlodipine
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vascular Diseases
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Amlodipine
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009